Ch. 11 — Regulation of Genetic Engineering • 221 
those done with E. coli K-12, were exempted 
from the MUA rec|uirement. 
The aholition of the Ml^A essentially abol- 
ished centralized Federal monitoring of rDNA 
experiments. The only current (iuideline provi- 
sion that ser\ es this kind of monitoring function 
is the requirement that the institution, the IBC, 
or the PI notify OKD.A of any significant \ iola- 
tions, accidents, or problems with interpreta- 
tion. lamited monitoi'ing of large-scale acti\ ities 
continues. Under \'IH procedures (which are 
not part of the Ciuidelines) for re\ iewing appli- 
cations for exemptions from the 10-1 limit, the 
application must include a copy of the registra- 
tion document filed with the IBC. Fhe manufac- 
turing facilities may also he inspected by NIH, 
not for regulatory purposes, but to gather infor- 
mation for updating its I'ecommended large- 
scale containment levels. The aholition of the 
ML’.A is consistent with traditional views that 
Government should not interfere with basic sci- 
entific research. \\ hether or not it will reduce 
either the incentive to comply with the Guide- 
lines or the likelihood of discovering violations 
remains to be seen. 
THE DECISIONMAKING PROCESS 
Another way to evaluate the Guidelines be- 
sides considering their substantive require- 
ments is to look at the process by which they 
were formulated. In a situation where there is 
uncertainty and even strong disagreement 
about the nature, scope, and magnitude of the 
risks, it is difficult to judge whether or not a 
proposed solution to a problem will be a good 
one. Society’s confidence in the decisionmaking 
process and in the decisionmakers then be- 
comes the issue. As David L. Bazelon, Chief 
Judge of the U. S. Court of Appeals for the Dis- 
trict of Columbia, has stated:^® 
When the issues are controversial, any deci- 
sion may fail to satisfy large portions of the com- 
munity. But those who are dissatisfied with a 
particular decision will be more likely to ac- 
quiesce in it if they perceiv’e that their view's and 
interests were given a fair hearing. If the deci- 
sion-maker has frankly laid the competing con- 
siderations on the table, so that the public 
knows the worst as well as the best, he is unlike- 
L. Bazelon. "Coping With Technology Through the Legal 
Process," 62 Cornell Law Review 817,825, June 1977. 
ly to find himself accused of high-handedness, 
deceit, or cover-up. W'e simply cannot afford to 
deal with these vital issues in a manner that in- 
V ites public cynicism and distrust. 
The manner in which the Guidelines them- 
selves evolved has been controversial. (For a 
detailed discussion see app. IIl-A.) Initially, the 
scope and nature of the problem was defined by 
the scientific community; NIH organized RAC 
along the lines suggested by tbe NAS committee 
letter referred to in app. III-A. One of the goals 
of RAC was to recommend guidelines for rDNA 
experiments; it was not charged with consider- 
ing broader ethical or policy issues or the funda- 
mental question of whether the research should 
have been permitted at all. The original Guide- 
lines were produced by a committee having 
only one nonscientist. 
In late 1978, the Secretary of HEW signif- 
icantly restructured RAC and modified the 
Guidelines in order to increase the system’s 
accountability to the public, to "provide the op- 
portunity for those concerned to raise any 
ethical issues posed by recombinant DNA re- 
search", and to make RAC "the principal ad- 
visory body ... on recombinant DNA policy. 
However, it has remained in large part a tech- 
nically oriented body. Its charter was not 
changed in this respect; the Guidelines them- 
selves state that its advice is "primarily scientific 
and technical,” and matters presented for its 
consideration have continued to be mostly tech- 
nical. One area where RAC has played a signifi- 
cant policy role, however, is in dealing with the 
issue of voluntary compliance by industry. 
It could be argued that the system did provide 
for sufficient public input into the formulation 
of the problem* and that no other formulation 
was realistic. The two meetings in 1976 and 
1977 of the NIH Director’s Advisory Committee 
and the hearing chaired by the general counsel 
of HEW in the fall of 1978 provicfed the oppor- 
tunity for public comment on the overall Fed- 
^Uoseph A. Califano, "Notice of Revised Guidelines— Recombi- 
nant DNA Research," 43 F.R. 60080-60081, Dec. 22, 1978. 
'The problem was conceived in terms of how to permit the re- 
search to be done while limiting the physical risks to an acceptable 
level. Other formulations were possible, the broadest being how 
to limit all risks, including cultural ones, to an acceptable level. 
Such a formulation could have resulted in a prohibition of the 
research. 
